srobinson on DSK4SPTVN1PROD with NOTICES

34950 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices 

Rockville, MD 20852. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–402–2071. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance document. 

You may submit comments identified 

by docket ID number HHS–OS–OPHS– 

2012–0005, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Enter the above 

docket ID number in the ‘‘Enter 

Keyword or ID field and click on 

‘‘Search.’’ On the next page, click the 

‘‘Submit a Comment’’ action and follow 

the instructions. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received, including any 

personal information, will be posted 

without change to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, 240–453–6900; email 

Irene.Stith-Coleman@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Overview 

OHRP, Office of the Assistant 

Secretary for Health, is announcing the 

availability of a draft guidance 

document entitled ‘‘Draft Guidance on 

Considerations in Transferring a 

Previously-Approved Research Project 

to a New IRB or Research Institution.’’ 

The draft guidance document, when 

finalized, will represent OHRP’s current 

thinking on this topic and will provide 

OHRP’s first formal guidance on this 

topic. The draft document is intended 

primarily for IRBs, institutions, and 

investigators that may be responsible for 

the review, conduct, or oversight of 

human subjects research conducted or 

supported by HHS. 

The guidance document would apply 

to non-exempt human subjects research 

conducted or supported by HHS. It 

presents common scenarios for transfer 

of a previously-approved research 

project to another institutional review 

board (IRB) or to a new engaged 

research institution, and outlines the 

administrative actions to be considered 

by IRBs, engaged institution(s), and 

investigators. In particular, the guidance 

addresses the following questions: 

1. What is the regulatory background 

for research project transfer? 

2. What actions may apply when the 

research project remains at the same 

institution, but responsibility for IRB 

review is transferred either from an 

internal to an external IRB, or from an 

external IRB to another external IRB? 

3. What actions may apply when the 

research project remains at the same 

institution, but responsibility for IRB 

review is transferred from one internal 

to another internal IRB? 

4. What actions may apply when the 

research project is transferred to a new 

engaged institution? 

To enhance human subject protections 

and reduce regulatory burden, OHRP 

and the Food and Drug Administration 

(FDA) have been actively working to 

harmonize the agencies’ regulatory 

requirements and guidance for human 

subjects research. 

FDA has simultaneously published in 

this same issue of the Federal Register 

a draft guidance document entitled 

‘‘Guidance for IRBs, Clinical 

Investigators, and Sponsors, 

Considerations When Transferring 

Clinical Investigation Oversight to 

Another IRB’’ that is similar to OHRP’s 

draft document. 

FDA and OHRP recognize that the two 

documents may appear somewhat 

different as there are minor variations in 

formatting and some necessary 

variations due to differences in the 

regulated entities under FDA’s and 

OHRP’s jurisdiction. The agencies wish 

to stress, however, that our intent was 

to provide harmonized guidance to 

IRBs, sponsors, institutions, 

investigators, and other entities 

involved in the study oversight transfer 

process. FDA and OHRP will continue 

to work closely in the development of 

final guidance and appreciate comments 

from interested parties. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance document 

on OHRP’s Web site at http:// 

www.hhs.gov/ohrp/newsroom/rfc/ 

index.html or on the Federal 

eRulemaking Portal at http:// 

www.regulations.gov/. 

Dated: June 7, 2012. 

Ivor Pritchard, 

Senior Advisor to the Director, Office for 

Human Research Protections. 

[FR Doc. 2012–14287 Filed 6–11–12; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the Clarksville Facility in Clarksville, 

TN, To Be Included in the Special 

Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

Clarksville Facility in Clarksville, 

Tennessee, to be included in the Special 

Exposure Cohort under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Clarksville Facility. 

Location: Clarksville, Tennessee. 

Job Titles and/or Job Duties: Workers 

potentially exposed to radioactive 

materials while working at the 

Clarksville facility. 

Period of Employment: January 1, 

1949 to December 31, 1967. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2012–14221 Filed 6–11–12; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the Medina Facility in San Antonio, TX, 

To Be Included in the Special 

Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice.